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[Cancer Research 60, 6921-6926, December 15, 2000]
© 2000 American Association for Cancer Research

Clinical Investigations

Polymorphisms of UDP-Glucuronosyltransferase Gene and Irinotecan Toxicity: A Pharmacogenetic Analysis1

Yuichi Ando, Hideo Saka, Maki Ando, Toshiyuki Sawa, Kei Muro, Hiroshi Ueoka, Akira Yokoyama, Soh Saitoh, Kaoru Shimokata and Yoshinori Hasegawa2

First Department of Internal Medicine, Nagoya University School of Medicine, Nagoya 466-8550 [Y. A., M. A., Y. H.]; Department of Internal Medicine, Nagoya National Hospital, Nagoya 460-0001 [H. S.]; Division of Respiratory Medicine, Gifu Municipal Hospital, Gifu 500-8323 [T. S.]; Department of Medical Oncology, National Cancer Center Hospital, Tokyo 104-0045 [K. M.]; Second Department of Medicine, Okayama University Medical School, Okayama 700-8558 [H. U.]; Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata 951-8566 [A. Y.]; Department of Gastroenterology, Aomori Prefectural Central Hospital, Aomori 030-8553 [S.S.]; and Department of Preventive Clinical Medicine, Nagoya University, Nagoya, 461-0047 [K. S.], Japan

Irinotecan unexpectedly causes severe toxicity of leukopenia or diarrhea. Irinotecan is metabolized to form active SN-38, which is further conjugated and detoxified by UDP-glucuronosyltransferase (UGT) 1A1 enzyme. Genetic polymorphisms of the UGT1A1 would affect an interindividual variation of the toxicity by irinotecan via the alternation of bioavailability of SN-38. In this case-control study, retrospective review of clinical records and determination of UGT1A1 polymorphisms were performed to investigate whether a patient with the variant UGT1A1 genotypes would be at higher risk for severe toxicity by irinotecan. All patients previously received irinotecan against cancer in university hospitals, cancer centers, or large urban hospitals in Japan. We identified 26 patients who experienced severe toxicity and 92 patients who did not. The relationship was studied between the multiple variant genotypes (UGT1A1*28 in the promoter and UGT1A1*6, UGT1A1*27, UGT1A1*29, and UGT1A1*7 in the coding region) and the severe toxicity of grade 4 leukopenia (<=0.9 x 109/liter) and/or grade 3 (watery for 5 days or more) or grade 4 (hemorrhagic or dehydration) diarrhea. Of the 26 patients with the severe toxicity, the genotypes of UGT1A1*28 were homozygous in 4 (15%) and heterozygous in 8 (31%), whereas 3 (3%) homozygous and 10 (11%) heterozygous were found among the 92 patients without the severe toxicity. Multivariate analysis suggested that the genotype either heterozygous or homozygous for UGT1A1*28 would be a significant risk factor for severe toxicity by irinotecan (P < 0.001; odds ratio, 7.23; 95% confidence interval, 2.52–22.3). All 3 patients heterozygous for UGT1A1*27 encountered severe toxicity. No statistical association of UGT1A1*6 with the occurrence of severe toxicity was observed. None had UGT1A1*29 or UGT1A1*7. We suggest that determination of the UGT1A1 genotypes might be clinically useful for predicting severe toxicity by irinotecan in cancer patients. This research warrants a prospective trial to corroborate the usefulness of gene diagnosis of UGT1A1 polymorphisms prior to irinotecan chemotherapy.




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R. H. Tukey, C. P. Strassburg, and P. I. Mackenzie
Pharmacogenomics of Human UDP-Glucuronosyltransferases and Irinotecan Toxicity
Mol. Pharmacol., September 1, 2002; 62(3): 446 - 450.
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J.-F. Gagne, V. Montminy, P. Belanger, K. Journault, G. Gaucher, and C. Guillemette
Common Human UGT1A Polymorphisms and the Altered Metabolism of Irinotecan Active Metabolite 7-Ethyl-10-hydroxycamptothecin (SN-38)
Mol. Pharmacol., September 1, 2002; 62(3): 608 - 617.
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D. F.S. Kehrer, R. H.J. Mathijssen, J. Verweij, P. de Bruijn, and A. Sparreboom
Modulation of Irinotecan Metabolism by Ketoconazole
J. Clin. Oncol., July 15, 2002; 20(14): 3122 - 3129.
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K. R. Crews, C. F. Stewart, D. Jones-Wallace, S. J. Thompson, P. J. Houghton, R. L. Heideman, M. Fouladi, D. C. Bowers, M. M. Chintagumpala, and A. Gajjar
Altered Irinotecan Pharmacokinetics in Pediatric High-Grade Glioma Patients Receiving Enzyme-inducing Anticonvulsant Therapy
Clin. Cancer Res., July 1, 2002; 8(7): 2202 - 2209.
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H. L. McLeod
Genetic Strategies to Individualize Supportive Care
J. Clin. Oncol., June 15, 2002; 20(12): 2765 - 2767.
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Y. Ando, W. D. Figg, K. Noda, and N. Saijo
Irinotecan in Small-Cell Lung Cancer
N. Engl. J. Med., May 2, 2002; 346(18): 1414 - 1415.
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M. Steiner, P. Schuff-Werner, M. Freund, C.-H. Kohne, J. P. Stevenson, A. S. Whitehead, and P. J. O'Dwyer
Combined Chemotherapy Trials Require Combined Pharmacogenetic Approaches
J. Clin. Oncol., March 1, 2002; 20(5): 1425 - 1426.
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R. H.J. Mathijssen, J. Verweij, M. J.A. de Jonge, K. Nooter, G. Stoter, and A. Sparreboom
Impact of Body-Size Measures on Irinotecan Clearance: Alternative Dosing Recommendations
J. Clin. Oncol., January 1, 2002; 20(1): 81 - 87.
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H. Minami, H. Fujii, T. Igarashi, K. Itoh, K. Tamanoi, T. Oguma, and Y. Sasaki
Phase I and Pharmacological Study of a New Camptothecin Derivative, Exatecan Mesylate (DX-8951f), Infused Over 30 Minutes Every Three Weeks
Clin. Cancer Res., October 1, 2001; 7(10): 3056 - 3064.
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R. H. J. Mathijssen, R. J. van Alphen, J. Verweij, W. J. Loos, K. Nooter, G. Stoter, and A. Sparreboom
Clinical Pharmacokinetics and Metabolism of Irinotecan (CPT-11)
Clin. Cancer Res., August 1, 2001; 7(8): 2182 - 2194.
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